Logiq E10
by GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC EUDAMEDGUDID
Active
Ref LOGIQ E10 R2 to R3 UPGModel LOGIQ E10
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing GUDID | Number00195278439369 | Date5 Dec 2025 | StatusIn distribution |
| European Union | CE/MDR EUDAMED | Number8406821BUG00028H2 | Date2 May 2023 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
- European Union
- United States
Specification
- Trade Name
- Logiq
- Generic Name
- General-purpose ultrasound imaging system
- Device Name
- Logiq E10
- Model / Reference
- LOGIQ E10 EUDAMEDLOGIQ E10 R2 to R3 UPG EUDAMEDE10 R2 to R3 UPG GUDID
- Primary DI / UDI-DI
- 00195278439369
- Basic UDI-DI
- 8406821BUG00028H2
- FDA Product Code
- IYN, IYO
- EMDN Code
- Z11040101 Internal ultrasound scanners
- GMDN Term
- General-purpose ultrasound imaging system
- Device Class
- Class IIa EUDAMEDClass II GUDID
- Regulation Number
- 892.1550, 892.1560
- Market of Registration
- France
- Commercial Distribution
- In Commercial Distribution
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Model / Reference | LOGIQ E10 LOGIQ E10 R2 to R3 UPG | E10 R2 to R3 UPG |
| Device Class | Class IIa | Class II |
Manufacturer details
- EUDAMED SRN
- US-MF-000016119
- Authorised representative
- GE Medical Systems SCS FR-AR-000000344
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Properties
Show properties
Other properties (21)
- Sterile: No
- Single Use: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Incorporates Medicinal Product: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Lot / Batch Number: No
- Expiration Date: No
- Manufacturing Date: No